보건의료데이터의 안전한 활용을 위한 법제도 연구 - 핀란드의 보건 복지데이터의 이차 이용에 관한 법률 입법사례를 중심으로 -

윤혜선(Hyesun Yoon) 서울대학교 공익산업법센터 2021 경제규제와 법 Vol.14 No.2

데이터 기반 혁신을 추구하는 국제적 조류 속에서 고품질의 보건의료 빅데이터를 보유한 핀란드는 글로벌 보건의료 R&D 허브로 우뚝 서기 위해 많은 노력을 기울이고 있다. 이를 위한 실행 목표는 신뢰가능한 보건의료데이터 생태계를 조성하여 적어도 유럽연합 내에서 보건의 료데이터 활용에 있어서만큼은 선도국이 된다는 것인데, 이 목표를 달성하기 위하여 핀란드 정부는 국가 전략을 수립하고, 관련 법제도를 개선하고, 각종 프로젝트를 추진하는 등 체계적으로 실현 작업을 진행해 나가고 있다. 구체적으로 핀란드 정부는 데이터 경제라는 시대적⋅외생적 상황과 풍부한 가용 보건의료데이터를 보유하고 있다는 우위적 국내 현실에도 불구하고 GDPR에 의해 보건의료데이터의 이차 이용이 제한되는 법제도적 상황을 우선적으로 극복하기 위해 GDPR에서 과학적 연구에 관해 부여한 입법 재량을 행사하여 보건의료데이터에 관한 독자적인 법제와 거버넌스를 구축하였다. 2019년 5월 1일 제정된 「보건⋅복지데이터의 이차 이용에 관한 법률(이하 ‘「이차이용법」’)」은 바로 이러한 핀란드 정부의 자구적 노력의 소산이다. 이 법률은 사회적으로 가치 있는 목적 – 통계작성, 과학적 연구, 개발 및 혁신 활동, 교육, 지식관리, 규제 등 - 을 위해 보건⋅복지데이터를 광범위하게 활용하는 것을 장려한다. 또한 데이터를 필요로 하는 이용자에게 ‘원스톱쇼핑(one-stop-shop)’ 원칙에 따라 Findata라는 단일한 데이터허가기관을 통해서 데이터에 대한 접근권과 데이터 서비스를 제공하도록 하여 보건⋅복지데이터 활용 절차의 효율성과 신속성을 제고하였다. 나아가 「이차이용법」은 GDPR에서 요구하는 개인정보 보호 요건을 준수하면서 동시에 보건⋅복지데이터의 활용성을 높이기 위해 매우 엄격한 수준의 보안 요건도 제도화하였다. 이에 따라 「이차이용법」에 따른 보건⋅복지데이터에 대한 접근과 이용은 원칙적으로 Findata의 안전한 운영환경 안에서 원격으로만 가능하다. 핀란드의 「이차이용법」은 정보주체로서 개인의 권익 보호와 혁신 및 경제 성장이라는 국가적 당위 사이에 존재하는 긴장 관계를 실효적으로 완화시키는 제도적 수단이다. 현재 우리나라는 보건의료데이터의 보호와 활용을 둘러싸고 「이차이용법」 제정 이전 핀란드 정부가 직면했던 유사한 정책적 갈등 구조와 데이터 관리 환경에 놓여 있다. 이에 본고에서는 핀란드의 「이차이용법」 입법사례를 연구하여 제도적 시사점을 도출하였다. 구체적으로 핀란드의 보건의료데이터의 보호 및 이용에 관한 정책 및 법제 환경을 개관하고, 「이차이용법」의 체계와 주요 내용을 살핀 후, 이 법률의 의의와 한계를 평가하고, 국내에 대한 함의와 시사점을 검토하였다. Finland, a country with a vast amounts of high-quality health care data has recently made great efforts to stand out as a global health R&D hub within the international trend of pursuing data-based innovation. The Finnish government has established various strategies to create a health ecosystem, especially a reliable health data ecosystem, and is systematically carrying out implementation plans such as improving the legal system and promoting large projects. In particular, Finland aims to become a leader in the secondary use of health data within the EU. Accordingly, the Finnish government attempted to overcome the situation in which the secondary use of sensitive personal data such as health data is restricted by the EU GDPR in consideration of the rapid growth of the data economy and abundantly available health data at home. The Act on the Secondary Use of Health and Social Data (hereinafter the ‘Act’) enacted on May 1,2019 represents such effort. The purpose of this Act is to encourage and promote the use of health and social data for socially valuable purposes. The goal is to improve the efficiency, integration, and speed of data access and utilization by processing the data permit applications and the data requests as well as related data access for users in need of data within a single agency as an one-stop shop covering all processes. Finland has devised a new data management and access system for this. This is why there is growing interest in the Act: the system has been designed to maintain a very high level of security system while complying with the requirements of the GDPR. In principle, access to health and social data is only possible remotely via the secure hosting service in the secure operating environment under the Act. By enacting the Act, Finland has clarified the legal basis for enabling extensive secondary use of health data under the GDPR. It also laid the foundation for easing the tension between the protection of the rights of data subjects and a pursuit for economic growth. Korea faces a similar conflict situation and a data management environment that Finland has agonized for a long time. Also similarly, various measures are actively sought by the government to solve this issue. This study aims to contribute to such efforts. Therefore this paper has looked for practical implications by thoroughly examining the contents of the Act that Finland takes pride as the solution to providing values to all stakeholders. This paper first examined the structure and the main contents of the Act in detail (II), then evaluated the significance and limitations of the Act (III), and lastly, attempted to draw the implications for our issues (IV).

환경규제의 집행 효과 제고에 관한 一考

윤혜선(Yoon, Hyesun) 충북대학교 법학연구소 2017 法學硏究 Vol.28 No.1

This article aims to find better alternatives to improve the environmental enforcement in Korea. A particular attention has been drawn to the Environmental Enforcement Act of Canada(hereinafter the “EEA”). The implementation of the EEA, passed in June 2009 has recently begun in three stages. The EEA is particularly interesting to be examined because it was intended and thus enacted to make the environmental enforcement regimes more consistent across all federal legislation. The EEA amended nine existing environmental statutes administered by then the Environmental Canada and Parks Canada, and it created a new act entitled the Environmental Violations Administrative Monetary Penalties Act. The ambitious statute standardized the enforcement and penalty regimes of nine federal environmental acts by introducing stiffer fines, new sentencing powers and considerations, and measures aimed at strengthening the government s ability to investigate and prosecute violations. Specifically, the EEA has increased maximum fine amounts, established minimum fines for certain offences, imposed liability on corporate directors and officers, and provided for sentencing guidance for courts by establishing principles and purposes of sentencing and also by identifying relevant aggravating factors that should be taken into account when determining sentence. The EEA has directed fines to the Environmental Damages Fund which funds community organizations in environmental restoration and research projects. Furthermore, the EEA has created a new statute, the Environmental Violations Administrative Monetary Penalties Act(hereinafter, the “EVAMP Act”) to establish a system of administrative monetary penalties for the enforcement of the nine amended Acts. The stated purpose in establishing this system is to provide an alternative to the penal system and to supplement existing measures to enforce the environmental Acts. In light of the abovementioned developments, this article, first, explains the detailed background and impetus to enact the EEA in Canada, and, next, examines the significance and specifics of the changes that this act brought to the enforcement landscape of the federal environmental regulation, and the sentencing regime. Furthermore, this article explains some contentious issues brought before the House of Commons in the course of legislating the EEA Bill and, lastly, it tries to draw some practical implications for the improvement of the Korean environmental enforcement system.

캐나다 판례법상 행정조사의 절차적 공정성 법리에 관한 고찰

윤혜선(Yoon, HyeSun) 한양법학회 2012 漢陽法學 Vol.23 No.2

It is trite to say that administrative investigations are required to be conducted in accordance with the principle of due process of law in Korea. However, so far, there has not been many studies showing the implementation of the principle within the investigative process. This is maybe because it is inherently difficult to make generalizations about the issue of the procedural fairness in the investigative stage. The structure of administrative tribunals and agencies varies significantly, and different tribunals and agencies utilize different investigative processes. Furthermore, the types of power being exercised by investigating bodies are widely divergent. As a result, each case must be considered on the bases of the empowering legislation and the duties and powers of the investigator. This article examines the Korean administrative investigation system and the application of the principle of due process of law in the administrative investigation context. Also it analyses the duty of fairness in the investigative stage of administrative proceedings in Canadian jurisprudence and demonstrates how the doctrine of procedural fairness, which derived from the principle of natural justice, evolved into such a duty and how it shaped its contents, so as to provide insights into latest development and thinking of the principle of due process of law in Korea. In Canada, the duty of fairness in the investigative stage of administrative proceedings has evolved. Although at one time there was little room for the application of procedural fairness during investigations, it is likely that such a blanket statement no longer holds true. The courts appear to be expanding the scope of judicial review over administrative proceedings, including being more willing to hold investigators to higher standards. Determining what duties an administrative tribunal owes to an individual whose rights may be affected requires an examination of the statutory provisions in question and a review of the nature of the decision to be made, the relationship between the administrative body and the individual, and the effect of the decision on the individual’ rights.